Regulatory Framework for Paediatric Medicines in India
The tragic deaths of 25 children linked to contaminated cough syrup in India underscore the urgent need for a robust regulatory framework governing the distribution of paediatric medicines. Despite the Union Health Ministry's ban on certain cough syrup formulations for children under four, the persistence of such incidents highlights significant oversights in enforcement.
Regulatory Agencies and Responsibilities
- Central Drugs Standard Control Organisation (CDSCO): This body under the Directorate General of Health Services, Ministry of Health and Family Welfare, oversees large manufacturers and export approvals.
- State Drug Control Officers: These officers regulate the manufacture, sale, and distribution of drugs by small- and medium-scale manufacturers.
The focus should be on strengthening these agencies' roles and responsibilities rather than merely attributing blame for such tragedies.
Children's Protection under the Constitution
- Article 39(f): This article mandates the state to ensure that children are not abused and that their childhood is protected.
- Children constitute 39% of India's population, emphasizing the need for specific legislative focus.
Laws and Policies for Child Protection
India has approximately 13 laws specifically designed to protect children, ranging from the National Policy for Children 1974 to the India Newborn Action Plan 2014. However, these primarily focus on labour laws and preventing sexual exploitation, with insufficient emphasis on pharmacovigilance in paediatric drug distribution.
Challenges in Paediatric Pharmacology
- Children have different pharmacodynamic responses compared to adults, but most drug trials exclude children.
- Lack of paediatric-specific dosage guidelines often results in dangerous extrapolations from adult data.
The absence of specific policies for paediatric drugs in India contrasts with frameworks in the EU and US, which incentivize research into children's pharmaceuticals.
Essential Medicines and Financial Burden
- The concept of essential medicines is crucial for making life-saving drugs affordable and accessible.
- The WHO introduced an essential Medicine list for children (EMLc), but it requires regular updates by policymakers.
Safe Practices and Public Health Care
- Constant education for caregivers and pharmacists is essential.
- Mandatory label reading and correct dosage dispensation must be enforced, especially for over-the-counter medications.
- Regulating OTC medications for children is vital for public health, with particular attention to urban areas where use is more common.
Global Responsibility and Data Specificity
- India's significant role as a global supplier of pharmaceuticals necessitates stringent safety protocols.
- Health policies should be based on Indian-specific data rather than extrapolated from adult or international data.
The overarching need is for a comprehensive and holistic infrastructure to ensure the safe use of medicines for children, respecting their rights and ensuring their protection.